Web-Based Communication Education for Breast Cancer Survivorship Care

This two-phase research plan will develop and test a culturally relevant, web-based patient education program, hereafter known as E-Talkcare. The intervention aims to empower Chinese cancer patients to effectively communicate with different providers in different healthcare settings.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Other: E-Talkcare; Other: Usual Care

Detailed Description

This two-phase study develops and tests the usability and efficacy of a culturally relevant, web-based patient education program, hereafter known as E-Talkcare, in improving Chinese immigrant breast cancer survivors' competence, perceived control, and self-efficacy in cancer care communication (intermediate outcomes), and patient-reported symptoms, adherence to breast cancer survivorship care guidelines, and quality of life (distal outcomes) versus the usual care control arm. In Phase I, community-based participatory research (CBPR) principles will be used to develop the intervention to educate participants about culture and communication by demonstrating how to ask for and verify information with doctors and use personalized symptom reports, and by providing question prompt lists for doctor visits. In Phase II, the intervention will be tested in a pilot randomized control trial (RCT). Using cases from Los Angeles Cancer Surveillance Program, California Cancer Registry, Maryland Cancer Registry, and clinics from California, 118 Chinese immigrant women (diagnosed with stage 0-III breast cancer and 1-3 years post-diagnosis) will be enrolled and randomized to either the E-Talkcare intervention or a usual care control arm. Participants will be interviewed via telephone at baseline (i.e., pre-randomization), 3-, and 6-months post-randomization.

• Study Type: Interventional
• Enrollment (Anticipated): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • Georgetown University
      • Contact: Judy Wang, PhD; Phone Number: 202-687-6306; Email: jw235@georgetown.edu
      • Principal Investigator: Judy (Huei_Yu) Wang, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Eligible Chinese women

• ≥ age 18
• foreign-born speaking Mandarin and/or Cantonese,
• diagnosed with breast cancer at stage 0, I, II or III,
• 1-3 years post-diagnosis and completed primary treatment (surgery, radiation, and chemotherapy); and
• no recurrence, and 6) internet access.

Exclusion Criteria:

• Women with other cancer types are ineligible due to different treatment complications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-Talkcare Group; use the web-based patient education tool	Other: E-Talkcare; Women in the intervention group will receive the E-Talkcare web address, a user name, and a temporary password. The participant will be able to read or listen (through audio narration) to instructions on how to complete the intervention in order, though she can freely navigate between web modules. Each module will have an ever-present indicator (showing users' progress) and a link to for users to continue navigating through modules.We will ask participants to complete the full intervention within 3 months after intervention delivery and then complete a 3-month post-randomization interview (T1). The website will remain open for six months after intervention delivery to allow participants to use QPL if they wish. A 6-month post-randomization interview (T2) will then be administered.
Placebo Comparator: Usual Care Group; receive usual care	Other: Usual Care; Survivors randomized to the usual care group will receive care from their doctors as usual, allowing us to compare the intervention against real-world practice to inform next steps. Since we do not know if the intervention will be efficacious, we decided not to provide a delayed intervention to control participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Communication Competence Scale	16 items to assess information provision, seeking, and verifying; α=.80-.89.	6 months
Assessment of Patient Experiences of Cancer Care	10-item patient-reported communication quality with follow-up care doctors; α=.75 in Chinese	6 months
Decision-making Participation Self-efficacy Scale	5-item measure of patient's efficacy in engaging in medical communication; α=.89 in Chinese	6 months
Perceived Personal Control Scale	4-item measure of patients' perceived personal control over breast cancer; α=.71 in Chinese	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Fatigue	6 items (e.g., felt tired, exhausted, limited at work); α=.97	6 months
PROMIS Sleep Disturbance	6 items (e.g., sleep not steady, unsatisfied, hard to fall asleep); α=.98	6 months
PROMIS Pain Interference	6 items (e.g., affecting ability to focus, interact with others, run errands); α=.95	6 months
PROMIS Cognitive Function	6 items (e.g., had trouble concentrating, slow thinking, hard to concentrate); α=.95	6 months
PROMIS Physical Function	8 items (e.g., carry heavy objects, kneeling, doing 2-hour labor work); α=.90	6 months
PROMIS Anxiety	7 items (e.g., felt anxious, nervous, fearful, tense); α=.90	6 months
PROMIS Depression	8 items (e.g., felt helpless, depressed, unhappy, hopeless); α=.90	6 months
Side/late Effect Assessments	31-item measure of patient-reported side/late effects from breast cancer treatment	6 months
Adherence to Breast Care Guidelines	26 yes-no items: receiving breast cancer follow-up care recommendations from doctors	6 months

Collaborators and Investigators

• Sponsor: Georgetown University
• Investigators: Principal Investigator: Judy Wang, Ph.D., Georgetown University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Survivorship Care; Chinese American Women; Provider-patient Communication
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2016-1407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No